Actively Recruiting
The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction
Led by yilong Wang · Updated on 2025-01-28
134
Participants Needed
6
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.
CONDITIONS
Official Title
The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- First stroke or previous stroke with full self-care (mRS 0-1)
- Treatment can start within 24 hours of stroke symptom onset
- Clinical and imaging diagnosis of cerebral infarction in the middle cerebral artery area
- NIH Stroke Scale score between 16 and 32 with motor arm and leg scores totaling at least 6
- Imaging showing core infarct area consistent with study criteria
- NIH Stroke Scale not improving or worsening after reperfusion therapy with total score still 32 or below
- Signed informed consent
You will not qualify if you...
- Other cerebrovascular diseases such as acute cerebral hemorrhage or subarachnoid hemorrhage
- Acute posterior circulation infarction or severe stenosis over 70%
- Bilateral cerebral infarction involvement
- Intracranial artery dissection, vasculitis, moyamoya disease, or other specific causes
- Hemorrhage transformation covering 30% or more of infarction area with space-occupying effect
- Signs of brain herniation or unstable vital signs due to cerebral edema
- Planned craniotomy decompression before randomization
- Uncontrolled high or low blood pressure
- Abnormal blood glucose levels before randomization
- Significant liver or kidney function abnormalities
- Recent acute myocardial infarction or severe heart failure
- Contraindications to intracalvariosseous injection such as recent skull fracture or infection
- Bleeding disorders or low platelet count
- Severe anemia
- Severe respiratory diseases requiring advanced support
- Serious infections
- Severe degenerative or psychiatric diseases
- Life expectancy under 3 months due to other conditions
- Allergy to study drugs or contrast agents
- Pregnancy, breastfeeding, or planning pregnancy
- Unable to comply with study protocols or follow-up
- Other reasons deemed unsuitable by investigators
- Participation in other interventional clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
The first affiliated hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
2
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
3
North China University of Science and Technology Affiliated Hospital
Tangshan, Heibei, China
Actively Recruiting
4
Tangshan Municipal Worker's Hospital
Tangshan, Heibei, China
Withdrawn
5
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Actively Recruiting
6
Tianjin Huanhu hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Yilong Wang, PhD+MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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